Alzamend Neuro presents lithium brain imaging results from phase 1/2a trial

Alzamend Neuro, Inc. furnished slides to the SEC as an exhibit to a Form 8-K dated September 29, 2026. The slides come from a presentation at the ISMRM Workshop on Advances in X-Nuclei MR on September 29, 2026, given by Ovidiu C. Andronesi of Massachusetts General Hospital and Harvard Medical School. The speaker disclosed sponsored research funding from Alzamend Neuro. The work reports pharmacokinetic imaging of lithium at 7 Tesla in a phase 1/2a clinical trial of AL001, a novel organic lithium salt.

The trial design

The slides describe a design of 30 participants in five groups of six: healthy volunteers, people with bipolar disorder, people with major depression, people with Alzheimer's disease and people with PTSD. The design is randomized, longitudinal and crossover, with all participants receiving both AL001 and lithium carbonate, Li2CO3, across two 14-day periods. The trial is registered as NCT06921590.

AL001 is a co-crystal of lithium salicylate and L-proline, called the LISPRO crystal. The slides say it is designed for better brain delivery with less systemic exposure than inorganic lithium salts. They note that lithium is the gold standard treatment for bipolar disorder and is also used in major depressive disorder, schizophrenia and Alzheimer's disease. Its narrow therapeutic window requires careful monitoring for renal, thyroid and other systemic toxicity risks.

Imaging and image quality

The scans used a Siemens Healthineers Terra.X 7 Tesla scanner. Voxels measured 8 cubic centimeters, or 20 mm isotropic.

Radiologists scored lithium image quality on a five-point scale. The primary analysis gave a Gwet's agreement coefficient of 0.73, with a 95% confidence interval of 0.66 to 0.80, which the slides label substantial agreement. A sensitivity analysis that did not assume complete independence gave 0.61, with an interval of 0.28 to 0.83. The slides say 92% of the 96 images scored between adequate and excellent.

Results in the healthy cohort

The slides report that 7 Tesla scanning gave higher signal and allowed quantification of brain lithium concentration over the pharmacokinetically relevant range of 694 to 6941 ng/g, at anatomical resolution. They report a trend toward slightly higher brain lithium after AL001, with a non-compartmental area under the curve geometric mean of 62230 h ng/g, compared with 59715 h ng/g for lithium carbonate. Brain region analysis showed slightly larger values in white matter than in gray matter.

The slides say the differences between AL001 and lithium carbonate are not statistically significant, in line with the small sample size. Modeling showed trends toward higher gray matter lithium and higher plasma-to-brain transfer in white matter after AL001. The slides say these trends generate hypotheses to be tested in subsequent patient cohorts, including bipolar disorder, major depression, Alzheimer's disease and PTSD.

The company's financial position

Alzamend Neuro reported research and development expense of $3.6 million for the fiscal year ended April 30, 2026, up from $1.4 million a year earlier. Its net loss for that year was $8.8 million, up from $4.5 million, and cash used in operations was $8.1 million, up from $6.6 million. Year-end cash and cash equivalents were $710,689, against $3.9 million a year earlier. Cash and cash equivalents were $7.6 million at July 31, 2026, according to its 10-Q.

The company's 10-K, filed July 22, 2026, says management concluded that internal control over financial reporting was not effective as of April 30, 2026. The company identified a material weakness: it does not have enough accounting resources to perform sufficient reviews of manual journal entries and general ledger reconciliations. The company says it is formalizing its control documentation and strengthening supervisory reviews.

What the data do not show

The imaging work so far covers the healthy cohort only, with six participants, and the slides say the differences between AL001 and lithium carbonate are not statistically significant. The slides call the trends hypotheses and give no efficacy or safety results in patients. The company still has to show results in bipolar disorder, depression, Alzheimer's disease and PTSD. The $7.6 million of cash at July 31, 2026 is less than the $8.1 million used in operations in the last fiscal year. The filings also report ineffective internal control over financial reporting.

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